FDA Product Code
FDA Product Code GTY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3740
510(k) Clearances — 44 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 | Traditional | PDF ↗ |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | ACON Laboratories, Inc. | 2025-11-26 | Dual Track | PDF ↗ |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | Healgen Scientific,, LLC | 2022-03-16 | Traditional | PDF ↗ |
| K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | Quidel Corporation | 2017-12-21 | Dual Track | PDF ↗ |
| K141775 | SOFIA (R) STREP A+ FIA | Quidel Corporation | 2014-12-16 | Dual Track | PDF ↗ |
| K133343 | WONDFO RAPID STREP A TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2014-01-31 | Traditional | PDF ↗ |
| K123793 | SOFIA STREP A FIA | Quidel Corporation | 2013-06-17 | Traditional | PDF ↗ |
| K122718 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP | Becton, Dickinson and Company | 2013-02-06 | Traditional | PDF ↗ |
| K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 | Binax, Inc. | 2009-09-04 | Traditional | PDF ↗ |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Princeton BioMeditech Corp. | 2008-10-06 | Special | PDF ↗ |
| K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | Unipath , Ltd. | 2005-12-06 | Traditional | PDF ↗ |
| K040708 | STATUS FIRST STREP A | Princeton BioMeditech Corp. | 2004-11-22 | Traditional | PDF ↗ |
| K031784 | ACON STREP A RAPID TEST DEVICE | ACON Laboratories, Inc. | 2003-07-14 | Special | PDF ↗ |
| K023766 | ACON STREP A TWIST TEST DEVICE | Acon Laboratories Co. | 2003-02-10 | Traditional | PDF ↗ |
| K023270 | SAS STREPALERT | Sa Scientific, Inc. | 2002-10-17 | Traditional | PDF ↗ |
| K013379 | SAS STREPALERT | Sa Scientific, Inc. | 2001-12-12 | Traditional | PDF ↗ |
| K011097 | QUICKVUE DIPSTICK STREP A | Quidel Corp. | 2001-05-08 | Traditional | PDF ↗ |
| K010582 | ACON STREP A RAPID TEST STRIP | Acon Laboratories Co. | 2001-05-07 | Traditional | PDF ↗ |
| K993456 | SAS STREP A TEST | Sa Scientific, Inc. | 2000-03-07 | Traditional | PDF ↗ |
| K992658 | OSOM ULTRA STREP A TEST, MODEL 147 | Wyntek Diagnostics, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K991828 | STREP B OIA | Biostar, Inc. | 1999-08-19 | Traditional | PDF ↗ |
| K982373 | UNI-GOLD STREP A TEST KIT | Trinity Biotech, Plc | 1999-02-11 | Traditional | PDF ↗ |
| K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | Princeton BioMeditech Corp. | 1998-11-25 | Traditional | PDF ↗ |
| K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST | Princeton BioMeditech Corp. | 1997-07-07 | Traditional | PDF ↗ |
| K945080 | QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS) | Quidel Corp. | 1995-02-10 | Traditional | PDF ↗ |
| K936112 | STREP B OIA | Biostar, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K935667 | QTEST(R) STREP | Becton Dickinson Advanced Diagnostics | 1994-04-21 | Traditional | PDF ↗ |
| K922765 | BIOSTARS STREP A OIA -- MODIFICATION | Biosearch Medical Products, Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K922490 | ABBOTT STREP A CONTROLS | Abbott Laboratories | 1992-07-22 | Traditional | PDF ↗ |
| K905020 | SLIDEX STREPTO-KIT | Vitek Systems, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K904589 | KODAK SURECELL(TM) STREP A CONTROL FLUID SET | Eastman Kodak Company | 1991-01-18 | Traditional | PDF ↗ |
| K902991 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1990-10-03 | Traditional | PDF ↗ |
| K882811 | STREPSLIDE | Ncs Diagnostics, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K864752 | ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL | Abbott Laboratories | 1987-02-26 | Traditional | PDF ↗ |
| K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST | Orion Diagnostica, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K862133 | HYGEIA RAPID STREP A TEST | Hygeia Sciences | 1986-06-25 | Traditional | PDF ↗ |
| K861575 | DIRECTATEX STREP A | Pacific Biotech, Inc. | 1986-06-03 | Traditional | PDF ↗ |
| K840512 | STREPTOCOCCUS PNEUMONIAE CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K840513 | STREPTOCOCCUS GR. B CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K840511 | STREPTOCOCCUS GR. D | Scientific Device Laboratory, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K840048 | PHADEBACT CSF POSITIVE CONTROLS | Pharmacia, Inc. | 1984-03-02 | Traditional | PDF ↗ |
| K832248 | PHADEBACT STREP POSITIVE CONTROLS | Pharmacia, Inc. | 1983-09-01 | Traditional | PDF ↗ |
| K831599 | MERITEC-STREP GROUP A BETA-HEMOLYTIC | Meridian Diagnostics, Inc. | 1983-08-11 | Traditional | PDF ↗ |
| K812808 | BBL DIRECTIGEN TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-30 | Traditional | PDF ↗ |
Product code GTY · Class I · Microbiology. Data: openFDA.